Welcome to our dedicated page for Arcturus Therape news (Ticker: ARCT), a resource for investors and traders seeking the latest updates and insights on Arcturus Therape stock.
Arcturus Therapeutics Holdings Inc. (ARCT) is a clinical-stage RNA medicines company pioneering novel therapeutics and vaccines through its proprietary delivery platforms. This news hub provides investors and researchers with timely updates on the company's progress in developing self-amplifying mRNA (sa-mRNA) vaccines and rare disease treatments.
Access official press releases covering regulatory milestones, clinical trial developments, and strategic partnerships. Our curated collection includes updates on the LUNAR® delivery system's applications, STARR® mRNA technology advancements, and global collaborations like the ARCALIS joint venture in Japan.
Key updates include earnings reports, research publications, manufacturing expansions, and patent grants. Bookmark this page for direct access to primary source materials about ARCT's work in nucleic acid therapeutics, including programs targeting liver disorders, respiratory diseases, and infectious disease prevention.
For stakeholders tracking RNA medicine innovation, this repository offers organized chronological updates without promotional commentary. Check regularly for verified information about clinical-stage candidates and technology licensing agreements that demonstrate Arcturus' position in the biotechnology sector.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has scheduled its first quarter 2025 financial results announcement. The company will release its financial results for the quarter ended March 31, 2025, after market close on Monday, May 12, 2025.
A conference call and webcast will follow at 4:30 PM Eastern Time on the same day. Investors can access the call through domestic (1-800-267-6316) or international (1-203-518-9783) lines using the Conference ID: ARCTURUS.
Arcturus Therapeutics (Nasdaq: ARCT) has received Fast Track Designation from the U.S. FDA for its self-amplifying mRNA vaccine candidate ARCT-2304, targeting pandemic influenza A virus H5N1. The designation, granted for vaccines addressing serious conditions, will expedite the development and review process through enhanced FDA communication, priority review eligibility, and potential rolling review.
The Phase 1 clinical study for ARCT-2304 commenced in November 2024. The vaccine utilizes Arcturus' proprietary STARR® technology platform for next-generation mRNA vaccines. The project is fully supported by federal funds from the Department of Health and Human Services, specifically through BARDA under contract number 75A50122C0007.
Arcturus Therapeutics (ARCT) reported Q4 2024 financial results and pipeline updates. The company announced Phase 2 interim data for ARCT-032 (Cystic Fibrosis) and ARCT-810 (OTC deficiency) expected in Q2 2025. Q4 2024 revenues were $22.8M, down from $30.9M in Q4 2023, with a net loss of $30.0M ($1.11 per share).
Key highlights include European Commission approval for KOSTAIVE, the first approved sa-mRNA COVID-19 vaccine, and MHLW approval for commercial manufacturing in Japan. The company reported $293.9M in cash and equivalents as of December 31, 2024, with an expected runway until Q1 2027. KOSTAIVE generated approximately $28.0M in gross profit share, currently being credited against program costs.
Full-year 2024 results showed revenues of $152.3M (down from $166.8M in 2023) and a net loss of $80.9M ($3.00 per share). R&D expenses increased to $195.2M, primarily due to higher clinical trial costs for OTC, CF, COVID-19, and LUNAR-FLU programs.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company specializing in infectious disease vaccines and liver and respiratory rare diseases, has announced its participation in Leerink's Global Healthcare Conference 2025. The company will engage in a fireside chat session scheduled for Wednesday, March 12, 2025, at 10:40 a.m. Eastern Time in Miami. Interested parties can access the webcast through the Investor Relations/Events section of the Arcturus website.
Arcturus Therapeutics (Nasdaq: ARCT), a commercial messenger RNA medicines company, announced it will release its Q4 and full-year 2024 financial results after market close on March 6, 2025. The company, which focuses on developing infectious disease vaccines and liver and respiratory rare diseases treatments, will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day.
Investors can access the earnings call through domestic (1-800-267-6316) or international (1-203-518-9783) dial-in numbers using the Conference ID: ARCTURUS. A webcast link will also be available.
CSL (CSLLY) and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE®, the first self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. The approval follows a positive CHMP opinion from December 12, 2024, and is valid across all EU member states and EEA countries.
KOSTAIVE, already marketed in Japan, demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on positive data from multiple studies, including an integrated phase 1/2/3 study and Phase 3 booster trials, which showed higher immunogenicity results versus a conventional mRNA COVID-19 vaccine comparator.
CSL and Arcturus Therapeutics (ARCT) have received European Commission marketing authorization for KOSTAIVE®, the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for individuals 18 and older. The approval follows a positive CHMP opinion from the European Medicines Agency on December 12, 2024.
KOSTAIVE demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on data from multiple studies, including an integrated phase 1/2/3 study showing efficacy and tolerability, and Phase 3 booster trials.
The vaccine is already marketed in Japan and will be valid across all EU member states and EEA countries. CSL is working to optimize KOSTAIVE's formulation to better serve healthcare professionals and patients in Europe.
Arcturus Therapeutics (Nasdaq: ARCT) has announced the appointment of Dr. Moncef Slaoui as Chair Designate. Dr. Slaoui, who has been serving on the Company's Board of Directors since June 2024, brings extensive experience in the pharmaceutical and biotechnology industry. The company, which focuses on commercial messenger RNA medicines for infectious disease vaccines and rare diseases affecting liver and respiratory systems, is entering what it describes as a transformative year with multiple key data readouts expected across its pipeline.
Meiji Seika Pharma has received approval to add domestic manufacturing sites in Japan for KOSTAIVE®, their self-amplifying mRNA COVID-19 vaccine. The approval enables integrated production within Japan, with ARCALIS's Minami-soma facilities and Meiji Seika Pharmatech added as manufacturing sites.
The technology transfer was managed by CSL Seqirus, the global licensor of KOSTAIVE®. The domestic production includes manufacturing of active pharmaceutical ingredients at ARCALIS's facilities and formulation at Meiji Seika Pharmatech, allowing for commercial distribution in Japan. This development involves Arcturus Therapeutics' LUNAR® lipid nanoparticle formulation processes and STARR® sa-mRNA drug substance manufacturing technologies.
Arcturus Therapeutics (ARCT) has initiated a Phase 1 study of ARCT-2304 (LUNAR-H5N1), a self-amplifying mRNA vaccine candidate for pandemic H5N1 influenza prevention. The trial, fully funded by BARDA, began in December 2024 and aims to enroll approximately 200 healthy adults across multiple U.S. sites.
The randomized placebo-controlled study will evaluate three dose levels and two vaccination schedules, focusing on safety and immune responses measured through various assays. The vaccine utilizes LUNAR® delivery and STARR® mRNA technologies, which have previously demonstrated robust immune responses at low doses and extended neutralizing antibody persistence compared to conventional mRNA vaccines.
LUNAR-H5N1 becomes the third STARR® mRNA vaccine to enter clinical trials, with interim Phase 1 data expected in H2 2025. The technology's safety profile has been established through previous trials involving over 20,000 participants.
